CIPH Ciphergen Biosystems (MM)

Promising Results Published in JAMA on Biomarkers for Early Diagnosis of Infections Associated With Preterm Birth Discovery of Biomarkers Enabled by Ciphergen's ProteinChip(R) System FREMONT, Calif., Aug. 2 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (NASDAQ:CIPH) announced today that the SELDI ProteinChip(R) technology was used to discover several biomarkers that showed promising results in the early diagnosis of intra-amniotic infection (IAI), a major cause of preterm birth. This study, "Diagnosis of Intra-amniotic Infection by Proteomic Profiling and Identification of Novel Biomarkers," which was published in the June 28 issue of the Journal of American Medical Association (JAMA), also reported that these biomarkers could be detected in serum, suggesting that development of a non-invasive diagnostic test may be possible. Senior author of the study, Srinivasa R. Nagalla, M.D., Associate Professor and Director for Center for Biomarker Discovery at Oregon Health and Science University, stated, "Protein profiling using SELDI enabled the discovery of these biomarkers in both amniotic fluid and serum. Our findings hold promise for the future development of rapid and non-invasive assays to detect IAI during pregnancy, which would allow physicians to target women at high risk for premature delivery for specific therapeutic intervention such as antibiotics or anti-inflammatory drugs." "We applaud the research team involved in this work for their application of SELDI to this important medical issue, and look forward to continuing our support of their efforts in developing potential diagnostic assays," stated Gail S. Page, President of Ciphergen's Diagnostics Division. "Ciphergen's clinical proteomics platform, based on our core SELDI ProteinChip technology, is enabling researchers to rapidly discover, validate and characterize novel biomarkers," said Martin Verhoef, President of Ciphergen Biosystems. "This study demonstrates the importance of not predigesting the samples during biomarker discovery, thus allowing the discovery of novel proteolytically generated protein fragments that may carry diagnostic and mechanistic information." Despite improvements in prenatal care, preterm birth occurs in nearly 12% of births in the United States and recent studies suggest that IAI is implicated as a major cause. Preterm births are responsible for 80% of neonatal deaths not caused by congenital defects. The signs and symptoms of IAI are variable, and most existing diagnostic methods for IAI have poor sensitivity and specificity for early detection of IAI, or require amniocentesis, an invasive procedure. Early detection of IAI would open a window for therapeutic intervention with antibiotics or anti-inflammatory agents. The study reported in JAMA utilized SELDI to generate a protein profile from the amniotic fluid of primates with IAI and discovered overexpression of several clusters of biomarkers. These clusters were present as early as 12 hours after infection, indicating that they could be used for early detection. One of these biomarkers was present in the amniotic fluid of all 11 women with intraamniotic inflammation who delivered pre-term, in 2/11 women without intra-amniotic inflammation who delivered pre-term, and in none of the women who delivered at term. Analysis of the overexpressed cluster of proteins indicates the possibility of a basic intrauterine immune response to infection since one set of proteins (the calgranulins) are expressed by macrophages and by epithelial cells in acutely inflamed tissues. The second polypeptide from the cluster is a unique fragment of insulin-like growth factor binding protein-1 (IGFBP-1), indicating a potential protease-related mechanism in response to infection. The study also demonstrated that these markers could be detected in serum, suggesting that an early detection, non-invasive test could be developed. About Ciphergen Ciphergen's Biosystems Division develops, manufactures and markets a family of ProteinChip(R) Systems and services for clinical, research, and process proteomics applications, as well as a broad range of bioseparations media for protein purification and large scale production. ProteinChip Systems enable protein discovery, characterization, identification and assay development to provide researchers with predictive, multi-marker assay capabilities and a better understanding of biological function at the protein level. Ciphergen's Diagnostics Division is dedicated to the discovery of protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests that improve patient care; and to providing collaborative R&D services through its Biomarker Discovery Center(R) laboratories for biomarker discovery for new diagnostic tests as well as pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays. Additional information about Ciphergen can be found at http://www.ciphergen.com/. Safe Harbor Statement Note Regarding Forward-Looking Statements: For purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"), Ciphergen disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such forward-looking statements include statements regarding biomarkers discovered by Ciphergen that may prove useful as a diagnostic test for IAI, the use of ProteinChip technology to discover useful protein biomarkers that can act as novel drug targets or disease markers, develop and commercialize clinical diagnostics that improve patient care, the ability to provide services that lead to improved toxicology assays and diagnostic assays, and statements regarding our Diagnostics Division. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the possibility that biomarkers described in the JAMA paper or discovered in other programs may fail to validate in larger studies as either providing useful disease mechanism insights or as accurate diagnostics, the ProteinChip technology's ability to validate and/or develop protein biomarkers as novel drug targets, diagnostic or toxicology assays, and the Company's ability to successfully commercialize such tests. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-Q dated May 10, 2004 and amended May 20, 2004, for further information regarding these and other risks of the Company's business. NOTE: Ciphergen, ProteinChip, Biomarker Discovery Center and BioSepra are registered trademarks of Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: Sue Carruthers, Investor Relations of Ciphergen Biosystems, Inc., +1-510-505 2297 Web site: http://www.ciphergen.com/

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